510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022821Substantially Equivalent

Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E

Ideatrics, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022821 is the FDA 510(k) clearance record for ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E, a class II device, cleared for Ideatrics, Inc. on under FDA product code DZK (Wire, Fixation, Intraosseous). FDA records list one 510(k) clearance for Ideatrics, Inc. As of , FDA records show no recalls naming K022821.

Clearance record

Decision date
Received
(81 days to decision)
Product code
DZK Wire, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Ideatrics, Inc. 7341 S. Meadow Ct., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZK

Trailing 12 months

FDA records hold no clearances under product code DZK in the trailing twelve months.

FDA records show no clearances under product code DZK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260